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Under the supervision of a healthcare professional, Titan Ag 200 may be used for the management of:

• Wounds with moderate to heavy exudate. ●
• Partial thickness burns. ●
• Leg ulcers, pressure ulcers and diabetic ulcers.
• Surgical wounds (e.g. post-operative, wounds left to heal by secondary intent and ● donor/graft sites).
• . Traumatic wounds (e.g. abrasions and lacerations).
• Wounds prone to bleeding such as wounds that have been mechanically or surgically ● debrided or donor sites .

Titan Ag 200 Wound Dressing is a soft, conformable non-woven fabric made from a blend of cellulose fiber(s) impreqnated with metallic silver (in the form of silver nano-particles), sodium carboxymethyl cellulose fibres and strengthening cellulose fiber(s). The ionic silver released into the wound dressing when in contact with wound exudate or blood has an antibacterial effect on wound bacteria held within the dressing, preventing it from being colonized. The structure of the dressing remains intact through the gel formation. Debris and any bacteria absorbed in the wound exudate and retained within the dressing are removed when the dressing is changed.

The provided text describes the Titan Ag 200 wound dressing and its substantial equivalence to the predicate device, Aquacel Ag Extra (K121275). Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Notes on "Equivalent" and "Similar" in the context of this document: The document explicitly states that "Statistical analysis of the difference in results obtained for silver release over 7 days for the subject and predicate devices was statistically insignificant. Therefore the devices are deemed to have equivalent silver release." This suggests that "similar" or "equivalent" in this context means statistically comparable performance that meets the safety and effectiveness requirements.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes for the various performance tests (e.g., number of dressings tested for silver release, absorbency, or wet tensile strength).

• Data Provenance: The studies are described as non-clinical performance data, indicating they were conducted in a laboratory setting. There is also mention of a porcine wound healing study, which would be an in vivo animal study. The document does not specify the country of origin for these specific tests, but the submitting company is based in the United Kingdom.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The ground truth for performance testing is typically established by adhering to recognized international standards and test methods (e.g., AATCC 100 for antibacterial efficacy, British Pharmacopoeia for absorbency, ISO 10993 for biocompatibility). These standards define the methodology and acceptance criteria, rather than relying on expert consensus for each individual test result within the submission.

4. Adjudication Method for the Test Set

This information is not applicable in the context of the performance testing described. The tests are objective measurements against established standards, not subjective assessments requiring adjudication by multiple readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study involving human readers is not described in this document. The studies focus on the physical and biological performance of the wound dressing itself, not on human interpretation or effectiveness with and without AI assistance. This device is a wound dressing, not an AI-powered diagnostic or therapeutic device.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

No, a standalone algorithm performance study was not done. This document pertains to a physical medical device (wound dressing), not a software algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance tests were based on:

• Standardized test methods and predetermined acceptance criteria: For silver release, absorbency, antibacterial activity, wet tensile strength, sterilization validation, and packaging integrity. These are objective measures against predefined thresholds.
• Biological evaluation standards (ISO 10993 series) and FDA guidance: For biocompatibility. This involves a battery of tests to assess different biological responses.
• Comparison to a legally marketed predicate device: The performance of the Titan Ag 200 was directly compared to the Aquacel Ag Extra (K121275) to demonstrate substantial equivalence.
• Porcine wound healing study: This is an in vivo animal model used to assess the device's effect on the wound healing process.

8. The Sample Size for the Training Set

This information is not applicable as this document describes a physical medical device (wound dressing) and its performance testing, not a machine learning or AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as this document describes a physical medical device (wound dressing) and its performance testing, not a machine learning or AI algorithm that requires a training set.

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Suprasorb® A +Ag Calcium Alginate Dressing with Antibacterial Silver can be used for the management of wounds which are: Moderately and heavily exuding, Superficial or Deep, Such as: Pressure sores, Arterial Ulcers, Venous lower leg ulcers, Diabetic ulcers, Post-operative wounds.

Suprasorb® A + Ag Calcium Alginate Dressings with Antibacterial Silver are soft, conformable wound covers with a high mannuronic acid content. The silver-impregnated calcium alginate fibres, when in contact with wound exudate or blood, form a gel which creates a moist wound healing environment. The silver in the wound dressing has an antibacterial effect upon various types of bacteria including Staphylococcus aureus and Escherichia Coli. The silver ions protect the dressing from a broad spectrum of bacterial contamination over a period of up to 3 days in the in vitro challenge test. Suprasorb® A + Ag Calcium Alginate Dressings with Antibacterial Silver are sterilized by irradiation and must not be re-sterilized. The products are sterile unless the package is opened or damaged. Suprasorb® A + Ag Calcium Alginate Dressings with Antibacterial Silver are for single use only.

The provided 510(k) summary for K071442, "Suprasorb® A +Ag Calcium Alginate Dressing with Antibacterial Silver," describes a new device and its substantial equivalence to predicate devices, but does not contain details of a clinical study or acceptance criteria in the typical sense for algorithm performance. Instead, it focuses on demonstrating comparable performance to existing, legally marketed devices through in vitro testing and biocompatibility assessments.

Therefore, the requested tables and specific study details in several sections cannot be fully completed as the document does not describe the types of studies pertinent to algorithm performance, expert ground truth, or MRMC studies.

Below is an attempt to structure the available information provided in the format requested, with specific notes where information is not present in the document.

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not applicable. The studies mentioned are in vitro tests and biocompatibility assessments, not a test set for an algorithm. No "data provenance" in the sense of patient data is relevant for these types of tests.
• Data Provenance: The biocompatibility tests were conducted in accordance with ISO 10993-1 and FDA Blue Book memorandum #G95-1. The in vitro tests for silver content, release, and absorbency, and antibacterial effect were also conducted. The country of origin for the device manufacturer is the U.K.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. This device is a medical dressing and its performance evaluation does not involve ground truth established by experts in the context of diagnostic algorithms or imaging. The "ground truth" for the performance characteristics (e.g., silver release, absorbency) would be determined by established laboratory measurement techniques, not expert consensus on medical cases.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable, as no test set in the context of expert review or algorithm output adjudication is mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is a wound dressing, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a wound dressing with antibacterial properties, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" for the device's performance characteristics (biocompatibility, silver content, silver release, absorbency, antibacterial effect) was established through laboratory testing and standardized in vitro methods according to relevant international standards (ISO 10993-1) and FDA guidance, and comparison to the performance of predicate devices. This does not involve expert consensus on clinical cases, pathology, or outcomes data in the context of diagnostic interpretation.

8. The sample size for the training set

• Not applicable. This device is a physical medical dressing, not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established

• Not applicable, as there is no training set for an algorithm.

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